Reporting by Chance Townsend, Caitlin Welsh, Sam Haysom, Amanda Yeo, Shannon Connellan, Cecily Mauran, Mike Pearl, and Adam Rosenberg contributed to this article.
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The PDUFA also allows drug companies to pay additional, voluntary fees to the agency to help pay for additional staffers—a move that has seen some positive benefits in an expedited review process. Although the FDA has an agreement in place with titans of the industry outlining metrics and timelines of such a process, those companies—and the FDA itself—have never directly paid staffers for meeting or exceeding timelines, until now.